Tag: FDA clearance
Nanowear’s Cloth-Based Wearable Remote Monitoring Platform SimpleSENSE Cleared By FDA
Nanowear, a leading connected-care and remote diagnostic platform, announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based diagnostic platform, SimpleSENSE....
Vitls Wins FDA Clearance For Its Remote Patient Monitoring Platform
Houston, Texas-based Vitls Inc. won FDA 510(k) clearance for its Vitls Platform. The Vitls Platform is a combination of a vitals monitoring patch, cloud...
Medtronic Wins FDA Clearance And CE Approval For LINQ II Insertable Cardiac Monitor
Medtronic, the global leader in medical technology, announced it has received U.S. FDA clearance and European CE Mark approval for its LINQ II insertable...
Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx Implantable Cardiac Monitor System
Boston Scientific has received FDA 510(k) clearance for its LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term implantable diagnostic device to detect arrhythmias...
Abbott’s Freestyle Libre 2 iCGM Receives FDA Clearance For Adults And Children With Diabetes...
Abbott, the worldwide leader in continuous glucose monitoring (CGM), received FDA clearance for its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for...
Propeller Health Receives FDA Clearance For Its Sensor To Work With Symbicort Inhaler
Propeller Health, a leading digital health company dedicated to the management of asthma and COPD, announced it has received 510(k) clearance from the US...